Alfadol-Ca caps 0.25 mcg+500 mg x100
Alfadol-Ca caps 0.25 mcg+500 mg x100 ATX code: A12AX (Calcium preparations in combination with other drugs)
Active substances
alfacalcidol Rec.INN WHO registered calcium carbonate Ph.Eur. European Pharmacopoeia
Dosage form
Alfadol-Sa
Capsulereg. No.: P N013997/01 dated 02/09/09 - Indefinitely Re-registration date: 10/22/15
Release form, packaging and composition of the drug Alfadol-Sa
Capsules 1 capsule.
alfacalcidol 0.25 mcg
calcium carbonate 500 mg,
which corresponds to a calcium content of 200 mg Clinical-pharmacological group: Drug that regulates calcium and phosphorus metabolism Pharmaco-therapeutic group: Calcium-phosphorus metabolism regulator
pharmachologic effect
A combined drug that regulates the metabolism of calcium and phosphorus. Replenishes the lack of calcium and vitamin D3 in the body.
The main therapeutic effects of alfacalcidol are an increase in the concentration of 1,25-hydroxycolecalciferol in the blood and, as a consequence, an increase in the absorption of calcium and phosphate, an improvement in mineralization and a decrease in bone resorption, a normalization of the content of parathyroid hormone in plasma, and a decrease in bone and muscle pain.
Calcium is involved in the formation of bone tissue, blood clotting, transmission of nerve impulses, contraction of skeletal muscles, and regulation of heart function.
Rationale for the combination of alfacalcidol and calcium
Alfacalcidol enhances the absorption of calcium from the gastrointestinal tract and causes a therapeutic effect in osteoporosis. The elemental calcium content in calcium carbonate is 40%, i.e. 500 mg of calcium carbonate contains 200 mg of elemental calcium, which corresponds to the minimum physiological requirement.
Pharmacokinetics
Absorption is high, TCmax is 8-18 hours. In the blood it binds to specific alpha globulins.
Metabolized in the liver to form the active metabolite calcitriol (1,25-dihydroxycolecalciferol), a smaller part is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, which allows it to be prescribed for vitamin D deficiency in patients with renal failure (the effect does not depend on hydroxylation in the kidneys).
It is excreted by the kidneys and bile in approximately the same amount.
Indications for the drug Alfadol-Sa
osteoporosis (menopausal, senile, steroid, idiopathic and others) and its complications (bone fractures), renal osteodystrophy, hypoparathyroidism and hyperparathyroidism (with bone damage), chronic renal failure. Open list of ICD-10 codes
ICD-10 code Indication
E55 Vitamin D deficiency
E58 Nutritional calcium deficiency
M80.0 Postmenopausal osteoporosis with pathological fracture
M80.1 Osteoporosis with pathological fracture after spayectomy
M80.4 Drug-induced osteoporosis with pathological fracture
M80.5 Idiopathic osteoporosis with pathological fracture
M81.0 Postmenopausal osteoporosis
M81.1 Osteoporosis after spayectomy
M81.4 Drug-induced osteoporosis
M81.8 Other osteoporosis (senile osteoprosis)
M82 Osteoporosis in diseases classified elsewhere
Dosage regimen
For osteoporosis - 1-2 capsules per day.
For osteodystrophy and chronic renal failure - 2 capsules per day.
For hypoparathyroidism and hyperparathyroidism (with bone damage) - 1-2 capsules per day.
Chronic renal failure - 1-2 capsules per day.
The duration of taking the drug is determined by the doctor.
Side effect
From the side of metabolic processes: hypercalcemia. In patients with severe renal impairment, hyperphosphatemia may develop.
From the digestive system: constipation, diarrhea.
From the urinary system: nephrocalcinosis.
Allergic reactions: itching, rash, urticaria.
Contraindications for use
increased sensitivity to vitamin D3, urolithiasis (formation of calcium stones), increased calcium levels in the blood (in persons with increased function of the parathyroid glands, hypervitaminosis D, osteochondrosis, metastases of tumors in the bones), hyperphosphatemia (except in cases where the latter develops against the background hypoparathyroidism), hypermagnesemia, Zollinger syndrome, peanut or soy intolerance, children under 18 years of age.
Take with caution to persons suffering from renal failure, as well as patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.
Use during pregnancy and breastfeeding
No studies have been conducted, so the drug is contraindicated during pregnancy and breastfeeding.
During pregnancy, the drug is prescribed only for absolute indications and only if the potential benefit of its use outweighs the possible risk to the fetus. Hypercalcemia during pregnancy may affect fetal development. The daily dose should not exceed 1500 mg of calcium carbonate.
Use for impaired renal function Take with caution to persons suffering from renal failure, as well as patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.
Use in children Contraindicated in children under 18 years of age.
special instructions
Alfacalcidol is an active derivative of vitamin D3. During treatment, therapeutic doses of vitamin D3 and its derivatives should not be prescribed due to the possibility of additive effects and an increased risk of hypercalcemia.
The drug enhances the intestinal absorption of calcium and phosphate, the concentration of which must be controlled, especially in patients with renal failure. Monitor concentrations of calcium, phosphate, alkaline phosphatase, magnesium and creatinine.
If hypercalcemia or hypercalciuria occurs, they can be quickly eliminated by discontinuing the drug until the plasma calcium concentration normalizes. The drug should be used with caution in patients with hypercalciuria, in particular in those with urolithiasis.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect driving or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
If hypercalcemia develops, you should stop taking the drug.
Hypercalcemia manifests itself as malaise, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, abdominal pain, gastrointestinal disorders, muscle pain, bone pain, joint pain, itching
Treatment: the drug should be discontinued. A severe form of hypercalcemia requires supportive treatment measures - hydration with the introduction of infusion saline solutions, in some cases - the appointment of “loop” diuretics and corticosteroids.
In cases of acute overdose, it is necessary to carry out preliminary treatment with gastric lavage and/or the introduction of mineral oil, which helps to reduce absorption and increase excretion of the drug through the intestines.
Drug interactions
Alfacalcidol/digitalis glycosides
Hypercalcemia in patients taking cardiac glycosides may exacerbate cardiac arrhythmia, and therefore their combined use should be avoided.
Alfacalcidol/barbiturates/anticonvulsants that are inducers of microsomal liver enzymes
Patients systematically receiving barbiturates or other anticonvulsants require increased doses of alfacalcidol to achieve a therapeutic effect.
Alfacalcidol/drugs affecting absorption
The absorption of alfacalcidol may be impaired by concomitantly taken mineral oils (with long-term use), cholestyramine, colestipol, sucralfate, as well as large quantities of aluminum-containing antacids.
When using alfacalcidol together with antacids and laxatives containing magnesium in patients on hemodialysis, the possibility of developing hypermagnesemia should be taken into account.
Alfacalcidol/thiazide diuretics
The interaction of alfacalcidol with thiazide diuretics increases the risk of developing hypercalcemia.
Calcium carbonate may interfere with the absorption of concomitantly taken tetracycline and ciprofloxacin.
Storage conditions for the drug Alfadol-Sa
In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.
Shelf life of the drug Alfadol-Sa Shelf life - 2 years.
Terms of sale
On prescription.
Alfadol-Sa
Alfadol-Ca caps 0.25 mcg+500 mg x100 ATX code: A12AX (Calcium preparations in combination with other drugs)
Active substances
alfacalcidol Rec.INN WHO registered calcium carbonate Ph.Eur. European Pharmacopoeia
Dosage form
Alfadol-Sa
Capsulereg. No.: P N013997/01 dated 02/09/09 - Indefinitely Re-registration date: 10/22/15
Release form, packaging and composition of the drug Alfadol-Sa
Capsules 1 capsule.
alfacalcidol 0.25 mcg
calcium carbonate 500 mg,
which corresponds to a calcium content of 200 mg Clinical-pharmacological group: Drug that regulates calcium and phosphorus metabolism Pharmaco-therapeutic group: Calcium-phosphorus metabolism regulator
pharmachologic effect
A combined drug that regulates the metabolism of calcium and phosphorus. Replenishes the lack of calcium and vitamin D3 in the body.
The main therapeutic effects of alfacalcidol are an increase in the concentration of 1,25-hydroxycolecalciferol in the blood and, as a consequence, an increase in the absorption of calcium and phosphate, an improvement in mineralization and a decrease in bone resorption, a normalization of the content of parathyroid hormone in plasma, and a decrease in bone and muscle pain.
Calcium is involved in the formation of bone tissue, blood clotting, transmission of nerve impulses, contraction of skeletal muscles, and regulation of heart function.
Rationale for the combination of alfacalcidol and calcium
Alfacalcidol enhances the absorption of calcium from the gastrointestinal tract and causes a therapeutic effect in osteoporosis. The elemental calcium content in calcium carbonate is 40%, i.e. 500 mg of calcium carbonate contains 200 mg of elemental calcium, which corresponds to the minimum physiological requirement.
Pharmacokinetics
Absorption is high, TCmax is 8-18 hours. In the blood it binds to specific alpha globulins.
Metabolized in the liver to form the active metabolite calcitriol (1,25-dihydroxycolecalciferol), a smaller part is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, which allows it to be prescribed for vitamin D deficiency in patients with renal failure (the effect does not depend on hydroxylation in the kidneys).
It is excreted by the kidneys and bile in approximately the same amount.
Indications for the drug Alfadol-Sa
osteoporosis (menopausal, senile, steroid, idiopathic and others) and its complications (bone fractures), renal osteodystrophy, hypoparathyroidism and hyperparathyroidism (with bone damage), chronic renal failure. Open list of ICD-10 codes
ICD-10 code Indication
E55 Vitamin D deficiency
E58 Nutritional calcium deficiency
M80.0 Postmenopausal osteoporosis with pathological fracture
M80.1 Osteoporosis with pathological fracture after spayectomy
M80.4 Drug-induced osteoporosis with pathological fracture
M80.5 Idiopathic osteoporosis with pathological fracture
M81.0 Postmenopausal osteoporosis
M81.1 Osteoporosis after spayectomy
M81.4 Drug-induced osteoporosis
M81.8 Other osteoporosis (senile osteoprosis)
M82 Osteoporosis in diseases classified elsewhere
Dosage regimen
For osteoporosis - 1-2 capsules per day.
For osteodystrophy and chronic renal failure - 2 capsules per day.
For hypoparathyroidism and hyperparathyroidism (with bone damage) - 1-2 capsules per day.
Chronic renal failure - 1-2 capsules per day.
The duration of taking the drug is determined by the doctor.
Side effect
From the side of metabolic processes: hypercalcemia. In patients with severe renal impairment, hyperphosphatemia may develop.
From the digestive system: constipation, diarrhea.
From the urinary system: nephrocalcinosis.
Allergic reactions: itching, rash, urticaria.
Contraindications for use
increased sensitivity to vitamin D3, urolithiasis (formation of calcium stones), increased calcium levels in the blood (in persons with increased function of the parathyroid glands, hypervitaminosis D, osteochondrosis, metastases of tumors in the bones), hyperphosphatemia (except in cases where the latter develops against the background hypoparathyroidism), hypermagnesemia, Zollinger syndrome, peanut or soy intolerance, children under 18 years of age.
Take with caution to persons suffering from renal failure, as well as patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.
Use during pregnancy and breastfeeding
No studies have been conducted, so the drug is contraindicated during pregnancy and breastfeeding.
During pregnancy, the drug is prescribed only for absolute indications and only if the potential benefit of its use outweighs the possible risk to the fetus. Hypercalcemia during pregnancy may affect fetal development. The daily dose should not exceed 1500 mg of calcium carbonate.
Use for impaired renal function Take with caution to persons suffering from renal failure, as well as patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.
Use in children Contraindicated in children under 18 years of age.
special instructions
Alfacalcidol is an active derivative of vitamin D3. During treatment, therapeutic doses of vitamin D3 and its derivatives should not be prescribed due to the possibility of additive effects and an increased risk of hypercalcemia.
The drug enhances the intestinal absorption of calcium and phosphate, the concentration of which must be controlled, especially in patients with renal failure. Monitor concentrations of calcium, phosphate, alkaline phosphatase, magnesium and creatinine.
If hypercalcemia or hypercalciuria occurs, they can be quickly eliminated by discontinuing the drug until the plasma calcium concentration normalizes. The drug should be used with caution in patients with hypercalciuria, in particular in those with urolithiasis.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect driving or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
If hypercalcemia develops, you should stop taking the drug.
Hypercalcemia manifests itself as malaise, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, abdominal pain, gastrointestinal disorders, muscle pain, bone pain, joint pain, itching
Treatment: the drug should be discontinued. A severe form of hypercalcemia requires supportive treatment measures - hydration with the introduction of infusion saline solutions, in some cases - the appointment of “loop” diuretics and corticosteroids.
In cases of acute overdose, it is necessary to carry out preliminary treatment with gastric lavage and/or the introduction of mineral oil, which helps to reduce absorption and increase excretion of the drug through the intestines.
Drug interactions
Alfacalcidol/digitalis glycosides
Hypercalcemia in patients taking cardiac glycosides may exacerbate cardiac arrhythmia, and therefore their combined use should be avoided.
Alfacalcidol/barbiturates/anticonvulsants that are inducers of microsomal liver enzymes
Patients systematically receiving barbiturates or other anticonvulsants require increased doses of alfacalcidol to achieve a therapeutic effect.
Alfacalcidol/drugs affecting absorption
The absorption of alfacalcidol may be impaired by concomitantly taken mineral oils (with long-term use), cholestyramine, colestipol, sucralfate, as well as large quantities of aluminum-containing antacids.
When using alfacalcidol together with antacids and laxatives containing magnesium in patients on hemodialysis, the possibility of developing hypermagnesemia should be taken into account.
Alfacalcidol/thiazide diuretics
The interaction of alfacalcidol with thiazide diuretics increases the risk of developing hypercalcemia.
Calcium carbonate may interfere with the absorption of concomitantly taken tetracycline and ciprofloxacin.
Storage conditions for the drug Alfadol-Sa
In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.
Shelf life of the drug Alfadol-Sa Shelf life - 2 years.
Terms of sale
On prescription.
